Redox Pharmaceutical Corporation's new antiviral and anti-inflammatory organometallic compound, CTC 96 (DoxovirTM) has demonstrated activity against herpes simplex virus (HSV) type-1 in cell culture and animal models of human ocular disease. The closely related HSV-2), which is the cause of millions and cases of genital herpes each year in the US, will be studied in animal models. In preliminary experiments, topical therapy with CTC 96 resulted in a reduced incidence of primary disease and reduced virus in the genital tract, accompanied by a reduction of subsequent spontaneous recurrence. This long-lasting effect following treatment of primary disease is unparalleled with currently available antiviral drugs. To verify these effects and to investigate the locus of therapeutic activity, established models of guinea pig genital herpes and mouse thermal reactivation will be used. Optimal CTC 96 concentration ranges for therapy and prophylaxis will be defined, and CTC 96 influence on the establishment of latency and replication of reactivated latent virus will be determined. Redox intends to pursue IND approval for testing of topical CTC 96 in human clinical trials of genital herpes as an objective of a Phase II SBIR application. PROPOSED COMMERCIAL APPLICATION: This research will clarify the potential use of Redox's antiherpetic agent (CTC 96; DoxovirTM) for therapy and prevention of primary genital herpes and recurrent infections. There are about 700,000 primary cases and 20 million recurrences annually in the US alone. Yearly worldwide sales of th leading antitherpetic drug, acyclovir, exceed $1 billion. DoxovirTM could also be useful for orofacial herpes (about 50,000,000 cases per year) and other dermal herpes infections (e.g., shingles). Potential markets include infectious disease specialists, dermatologists and general practitioners world-wide and their patients.